Drugs / Drotrecogin alfa (activated)
Drotrecogin alfa (activated)
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed infectious disease with sepsis 1 milestone | |||||
| Filed | US (FDA) | Zovant | infectious disease with sepsis | — | “Lilly submitted a biologics license application to the FDA in late January 2001 for drotrecogin alfa (activated).” lilly.com ↗ |
| Withdrawn Indication not stated 2 milestones | |||||
| Withdrawn | EU (EMA) | Xigris | — | 2011-11-28 | europa.eu ↗ |
| Approved | EU (EMA) | Xigris | — | 2002-08-22 | europa.eu ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT01227187 | Oct 2008 → Nov 2010 | end stage renal failure | George Washington University | Completed | No outcome recorded |
| Phase 2 | NCT00533546 | Sep 2007 → Oct 2010 | stroke disorder | University of Rochester | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00386425 | Nov 2006 → Aug 2009 | infectious disease with sepsis | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT00112164 | Jan 2005 → Feb 2007 | adult acute respiratory distress syndrome | University of California, San Francisco | Terminated | Missed primary |
| Phase 2 | NCT00191724 | Sep 2004 → Jan 2008 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 34 trials · 2 missed | ||||||
| Phase 3 | NCT00604214 | Mar 2008 → Sep 2011 | infectious disease with sepsis | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00190788 | Jun 2004 → May 2007 | hypotensive disorder, infectious disease with sepsis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00049764 | Nov 2002 → Apr 2005 | infectious disease with sepsis | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00568737 | Nov 2002 → Feb 2005 | infectious disease with sepsis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 45 trials · 2 missed | ||||||
| Phase 4 | NCT00279214 | Nov 2005 → Nov 2007 | infectious disease with sepsis | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT01017107 | Jun 2003 → Sep 2007 | acute pancreatitis | Helsinki University Central Hospital | Completed | Missed primary |
| Phase 4 | NCT00067730 | Mar → Oct 2003 | disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm, infectious disease with sepsis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00568893 | Jan → Oct 2003 | infectious disease with sepsis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00045760 | Sep 2002 → ? | infectious disease with sepsis | Eli Lilly and Company | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT01411670 Comparator | Jan 2011 → Feb 2015 | infectious disease with sepsis | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 3 | NCT00625209 Comparator | Mar 2008 → Jun 2015 | infectious disease with sepsis | University of Versailles | Completed | No outcome recorded |
| Phase 4 | NCT00049777 Background | Dec 2002 → Aug 2005 | infectious disease with sepsis | Eli Lilly and Company | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2011-10-25 | Eli Lilly and Company | Regulatory Lilly Announces Withdrawal of Xigris® Following Recent Clinical Trial Results lilly.com ↗
Eli Lilly and Company announces withdrawal of its Xigris(R) [drotrecogin alfa (activated)] product in all markets following results of the PROWESS-SHOCK study |
| 2001-11-21 | Eli Lilly and Company | Regulatory Lilly Receives FDA Approval to Market XigrisTM lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved XigrisTM (drotrecogin alfa [activated]), a breakthrough biotech therapy discovered and developed by Lilly. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2011-10-25 | Eli Lilly and Company | Lilly Provides Update on 2011 Financial Guidance Due to Xigris Withdrawal lilly.com ↗ |
| 2011-10-25 | Eli Lilly and Company | Lilly Announces Withdrawal of Xigris® Following Recent Clinical Trial Results lilly.com ↗ |
| 2011-05-23 | Eli Lilly and Company | Lilly and Investor Group Form New Critical Care Company BioCritica, Sign Xigris License Agreement lilly.com ↗ |
| 2007-02-26 | Eli Lilly and Company | Lilly Plans New Clinical Trial of Xigris(R) lilly.com ↗ |
| 2006-03-20 | Eli Lilly and Company | Lilly and Biosite to Collaborate on Clinical Trial Using Tailored Xigris Therapy lilly.com ↗ |
| 2001-11-21 | Eli Lilly and Company | Lilly Receives FDA Approval to Market XigrisTM lilly.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | drotrecogin-alfa (activated) | “INTRODUCTION: The aim of our study was to evaluate the clinical impact of the administration of intravenous steroids, alone or in conjunction with drotrecogin-alfa (activated)...” PMID 25928214 ↗ Apr 201513“A decade after drotrecogin alfa (activated) (DAA) was released on the market worldwide, its benefit-to-risk ratio remains a matter of debate.” PMID 23525934 ↗ May 2013 |
| Known as | Activated Protein C | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00533546 ↗ |
| Known as | APC | “The intervention consisted of APC (N = 16) administered intravenously for 96 hours with a dose of 24 μg/kg/hour or placebo (N = 16) with a similar infusion rate.” PMID 20663207 ↗ Jul 2010 |
| Known as | DAA | “A decade after drotrecogin alfa (activated) (DAA) was released on the market worldwide, its benefit-to-risk ratio remains a matter of debate.” PMID 23525934 ↗ May 2013 |
| Known as | DrotAA | “INTRODUCTION: The aim of our study was to evaluate the clinical impact of the administration of intravenous steroids, alone or in conjunction with drotrecogin-alfa (activated)...” PMID 25928214 ↗ Apr 20154“INTRODUCTION: Early multimodal treatment of severe sepsis, including the use of drotrecogin alfa (activated) (DrotAA) when indicated, is considered essential for optimum outcome.” PMID 19457240 ↗ May 2009 “Patients with severe sepsis frequently receive prophylactic heparin during drotrecogin alfa (activated) (DrotAA) treatment due to risk of venous thromboembolic events (VTEs).” PMID 17556722 ↗ Jun 2007 “Drotrecogin alfa (activated) (DrotAA) is used for the treatment of adults with severe sepsis who have a high risk of dying.” PMID 17350452 ↗ Mar 2007 “Administration of Drotrecogin Alfa [Activated] [DrotAA] in Early Stage Severe Sepsis” PMID 18786266 ↗ Sep 2008 |
| Known as | Xigris | “Xigris (drotrecogin alfa activated) is a recombinant form of human activated protein C” NCT01227187 ↗ |
| Action | Inhibit | “DAA infusion enhances the inhibition of fibrin formation.” PMID 21241489 ↗ Jan 2011 |
| Modality | Protein / enzyme biologic | “a recombinant form of human activated protein C” NCT00045760 ↗ |
| Route | Intravenous | “96-hour intravenous infusion of drotrecogin alfa (activated)” NCT00045760 ↗ |